EP1654027A2 - Catheter shaft for regulation of inflation and deflation - Google Patents
Catheter shaft for regulation of inflation and deflationInfo
- Publication number
- EP1654027A2 EP1654027A2 EP04779712A EP04779712A EP1654027A2 EP 1654027 A2 EP1654027 A2 EP 1654027A2 EP 04779712 A EP04779712 A EP 04779712A EP 04779712 A EP04779712 A EP 04779712A EP 1654027 A2 EP1654027 A2 EP 1654027A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- catheter
- shaft
- openings
- balloon
- tubular member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0014—Connecting a tube to a hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1038—Wrapping or folding devices for use with balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22061—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1034—Joining of shaft and balloon
Definitions
- the present invention pertains to angioplasty and angioplasty balloon catheters. More particularly, the present invention pertains to angioplasty balloon catheters that include one or more cutting edges.
- Background of the Invention Heart and vascular disease are major problems in the United States and throughout the world. Conditions such as atherosclerosis result in blood vessels becoming blocked or narrowed. This blockage can result in lack of oxygenation of the heart, which has significant consequences since the heart muscle must be well oxygenated in order to maintain its blood pumping action. Occluded, stenotic, or narrowed blood vessels may be treated with a number of relatively non-invasive medical procedures including percutaneous transluminal angioplasty (PTA), percutaneous transluminal coronary angioplasty (PTCA), and atherectomy.
- PTA percutaneous transluminal angioplasty
- PTCA percutaneous transluminal coronary angioplasty
- atherectomy percutaneous transluminal coronary angioplasty
- Angioplasty techniques typically involve the use of a balloon catheter.
- the balloon catheter is advanced over a guidewire so that the balloon is positioned adjacent a stenotic lesion.
- the balloon is then inflated, and the restriction of the vessel is opened.
- One of the major obstacles in treating coronary artery disease and/or treating blocked blood vessels is re-stenosis.
- Evidence has shown that cutting the stenosis, for example with an angioplasty balloon equipped with a cutting blade, during treatment can, in some situations, reduce the incidence of re-stenosis in some situations. Additionally, cutting the stenosis may reduce trauma at the treatment site and/or may reduce the trauma to adjacent healthy tissue.
- Cutting blades may also be beneficial additions to angioplasty procedures when the targeted occlusion is hardened or calcified. It is believed typical angioplasty balloons, alone, may not be able to expand these hardened lesions. Thus, angioplasty balloons equipped with cutting edges have been developed to attempt to enhance angioplasty treatments. There is an ongoing need for improved angioplasty devices, including cutting angioplasty balloons, and improved methods of treating intravascular stenoses and occlusions. Summary of the Invention The present invention relates to angioplasty balloon catheters.
- an example balloon catheter may include a catheter shaft having a balloon coupled thereto.
- the balloon may include one or more cutting members or blades attached thereto.
- the shaft may include one or more inflation lumens and a plurality of openings in fluid communi cation with the inflation lumen or lumens that may, for example, improve the regulation of inflation and deflation as well as improve the folding and refolding abilities of the balloon.
- Figure 1 is a partial cross-sectional side view of a vessel lumen having an example schematic medical device disposed therein;
- Figure 2 is a cross-sectional view of an example medical device;
- Figure 3 is a cross-sectional view of another example medical device;
- Figure 4 is a perspective view of a portion of an example catheter shaft;
- Figure 5 is a cross-sectional view of the catheter shaft taken through line 5-5 of Figure 4;
- Figure 6 is a cross-sectional view of another example catheter shaft.
- FIG. 1 illustrates an example angioplasty catheter 10 positioned in a blood vessel 12 adjacent an intravascular lesion or stenosis 14.
- Catheter 10 may include a balloon 16 coupled to a catheter shaft 18.
- Balloon 16 may include one or more cutting members 20 that can be used to cut or sever lesion 14.
- catheter 10 may be advanced over a guidewire 22 through the vasculature to a target area.
- Balloon 16 can then be inflated to expand lesion 14 and cutting members 20 can cut lesion 14.
- the target area may be within any suitable peripheral or cardiac location.
- Catheter shaft 18 may include an inner tubular member 24 and an outer tubular member 26, as shown in Figure 2.
- Inner tubular member 24 may include an inner lumen 27 that may be, for example, configured for having guidewire 22 disposed therein.
- Outer tubular member 26 may be generally disposed over inner tubular member 24 so that an inflation lumen 28 may be defined in the space therebetween.
- the distal end of outer tubular member 26 may be open so that inflation media can pass through inflation lumen 28 and out of the distal end to inflate balloon 16.
- outer tubular member 26 may extend into the expandable portion of balloon 16 and include a plurality of openings 30. Accordingly, inflation media can pass through inflation lumen 28, through openings 30, and into balloon 16.
- a plurality of selectively positioned openings 30 within outer tubular member 26 may be desirable for a number of reasons. For example, openings 30 may allow for greater regulation and control during inflation and deflation of balloon 16. This is because openings 30 can allow inflation media to be distributed along essentially the entire length of balloon 16 as well as across a greater portion of the balloon area. Accordingly, inflation and deflation can be regulated and controlled with greater consistency. The number of openings 30 may vary.
- outer tubular member 26 may include two or more, three or more, four or more, eight or more, sixteen or more, twenty or more, or any other suitable number of openings 30. Openings 30 may be dispersed in a number of different patterns and arrangements. For example, openings 30 may be grouped into one or more longitudinally aligned sets. However, openings 30 need not be longitudinally aligned or arranged in sets or groups. In Figure 2, two opposing sets of openings 30, positioned near the top and bottom of outer tubular member 26, are illustrated. It can be appreciated that this example balloon 16 may also include two additional opposing sets generally disposed along the front and rear faces of outer tubular member 26 but that are not visible in this partial cross-sectional view.
- outer tubular member 26 may include two, three, four, five, six, or more sets of openings 30.
- the number of openings 30 in each set may also vary and need not be the same among sets for a given outer tubular member 26.
- radially aligning openings 30 and cutting members 20 may also reduce twisting of balloon 16 during inflation that might otherwise create sheer forces between cutting members 20 and balloon 16.
- balloon 16 deflation may include venting inflation media.
- deflation may include applying a vacuum to lumen 24. Because of the arrangement of openings 30, venting and/or applying a vacuum to lumen 24 may allow regions of balloon 16 that are adjacent openings 30 to re-fold or deflate first. Accordingly, balloon 16 may have a more consistent and predictable re- folding pattern.
- radially and longitudinally aligning openings 30 with cutting members 20 may allow portions of balloon 16 that have cutting members 20 attached to be among the first portions to be deflated or moved radially inward.
- Balloon 16 may be made from typical angioplasty balloon materials including polymers such as polyethylene terephthalate (PET), polyetherimid (PEI), polyethylene (PE), etc.
- suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, polyurethane, polypropylene (PP), polyvinylchloride (PNC), polyether-ester (for example, a polyether-ester elastomer such as AR ⁇ ITEL® available from DSM Engineering Plastics), polyester (for example, a polyester elastomer such as HYTREL® available from DuPont), polyamide (for example, DURETHA ⁇ ® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example, available under the trade name PEBAX®), silicones, Marlex high-density polyethylene, Marlex low-density polyethylene, linear low
- tubular members 24/26 may be manufactured from a number of different materials.
- tubular members 24/26 may be made of metals, metal alloys, polymers, metal-polymer composites, or any other suitable materials.
- suitable metals and metal alloys include stainless steel, such as 304N, 304L, and 316L stainless steel; nickel-titanium alloy such as linear-elastic or super-elastic nitinol, nickel-chromium alloy, nickel-chrommm-iron alloy, cobalt alloy, tungsten or tungsten alloys, MP35- ⁇ (having a composition of about 35% Ni, 35% Co, 20% Cr, 9.75% Mo, a maximum 1% Fe, a maximum 1% Ti, a maximum 0.25% C, a maximum 0.15% Mn, and a maximum 0.15% Si), hastelloy, monel 400, inconel 825, or the like; or other suitable material.
- tubular members 24/26 may be arranged in any appropriate way.
- inner tubular member 24 can be disposed coaxially within outer tubular member 26.
- inner and outer tubular members 24/26 may or may not be secured to one another along the general longitudinal axis of catheter shaft 18.
- inner tubular member 24 may follow the inner wall or otherwise be disposed adjacent the inner wall of outer tubular member 26.
- inner and outer tubular members 24/26 may or may not be secured to one another.
- inner and outer tubular members 24/26 may be bonded, welded (including tack welding or any other welding technique), or otherwise secured at a bond point.
- the bond point may be generally disposed near the distal end of catheter shaft 18. However, one or more bond points may be disposed at any position along shaft 18.
- the outer shaft 26 is sealingly bonded to the outer surface of inner shaft 24 distal of the holes 30 so that inflation fluid does not enter the balloon through the end of the outer shaft lumen.
- the bond may desirably impact, for example, the stability and the ability of tubular members 24/26 to maintain their position relative to one another.
- inner and outer tubular member 24/26 may be substantially parallel to one another so that they are non-overlapping.
- shaft 18 may include an outer sheath that is disposed over tubular members 24/26.
- one or more marker members may be coupled to catheter 10.
- the marker members e.g., marker bands, coils, etc.
- the marker members may include, be made from, be doped with, or otherwise include a radiopaque material.
- Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of catheter 10 in determir-ting its location.
- Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, plastic material loaded with a radiopaque filler, and the like.
- Balloon 16 may be coupled to catheter shaft 18 in any of a number of suitable ways.
- balloon 16 may be adhesively or thermally bonded to shaft 18.
- a proximal waist portion 32 of balloon 16 may be bonded to shaft 18, for example at outer tubular member 26, and a distal waist portion 34 may be bonded to shaft 18, for example at inner tubular member 24.
- a proximal bond 36 and a distal bond 38 which each may represent an adhesive, thermal, mechanical, or other type of comiection, may be disposed adjacent proximal and distal waist portions 32/34. The exact bonding positions, however, may vary.
- a folding spring (not shown) may be coupled to balloon 16, for example adjacent proximal portion 36, which may further help in balloon folding and refolding. A description of a suitable folding spring can be found in U.S. Patent No.
- FIG. 3 Another example catheter 110 is shown in Figure 3.
- catheter 110 is similar to catheter 10 except that shaft 118 includes outer tubular member 126 that extends distally to a position adjacent distal waist portion 34 of balloon 16.
- This embodiment of shaft 118 allows balloon 16 to be attached at both its proximal and distal ends (e.g., waist portions 32/34) to outer tubular member 126, which may help to reduce balloon elongation as well as have other desirable effects.
- a different number of openings 130 in this case, a set of three openings 130 defined in outer tubular member 126. This simply demonstrates that a variety of different numbers and patterns of openings 130 may be used in any of the several catheter embodiments.
- Shaft 218 may include a plurality of lumens.
- a centrally located lumen 224 which may serve as a guidewire lumen, may extend through essentially the middle of shaft 218 and along the length thereof.
- a plurality of side lumens 228a/b/c/d may be defined in shaft 218.
- Balloon 16 can be attached to shaft 218 in a manner that is similar to what is described above. Side lumens 228a/b/c/d may be disposed radially from lumen 224.
- lumens 228a/b/c/d can vary and is not intended to be limited to four as shown.
- shaft 218 may include two, three, five, six, or more lumens similar to lumens 228a/b/c/d.
- lumens 228a/b/c/d are each coupled to openings 230 or a set of openings 230.
- the number of lumens 228a/b/c/d may be correlated to the number of sets of openings 230.
- shaft 218 may include four lumens 228a/b/c/d when four sets of longitudinally-aligned openings 230 are defined in shaft 218.
- inflation media can be directed to each set of openings 230 through one of lumens 228a/b/c/d. This may be desirable, for example, because it may allow each set of openings 230 to be controlled independently of one another.
- Shaft 218 may also be desirable because it need not include both inner and outer tubular members. This is because the multi-lumen configuration of shaft 218 is configured for both advancement over a guidewire and for inflating balloon 16. In addition, because fewer structural elements are included, shaft 218 may be constructed to have a lower profile than typical angioplasty catheter shafts and allow shaft 218 to be used in catheters that target smaller or more sensitive vascular locations such as the brain.
- Shaft 218 may be manufactured from any suitable material including the metals and polymers listed above as well as other appropriate material. The material chosen can be processed in order to define a shape and configuration similar to what is seen in Figure 4.
- shaft 218 may be made from a polymer that is extruded or molded (e.g., injection or other types of molding) into the desired shape.
- a cross-sectional view of shaft 218 is shown in Figure 5.
- shaft 218 may be generally cylindrical in shape and have an outside diameter (OD) of about 0.04 to about 0.06 inches or so.
- the diameter (D) of lumen 24 may be about 0.022 to about 0.028 inches.
- lumens 228a b/c/d have a cross-sectional area that is generally half-moon shaped or semi-circular.
- the length (L) of lumens 228a/b/c/d may be on the order of about 0.005 to about 0.025 inches or more and the height (H) of lumens 228a/b/c/d, for example, may be on the order of about 0.004 to about 0.010 inches or more.
- Lumens 228a/b/c/d may be spaced a distance (S) of about 0.005 to about 0.010 inches or so from lumen 224.
- Figure 5 illustrates lumens 228a/b/c/d as being generally half-moon shaped
- Figure 6 illustrates a cross-sectional view of another example shaft 318, similar to shaft 218, where lumens 328a/b/c/d have a cross-sectional area that is more cylindrical in shape or is more pill-shaped.
- the shape of lumens 328a/b/c/d are similar to lumens 228a/b/c/d, but with rounded ends.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Child & Adolescent Psychology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Surgical Instruments (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/637,142 US7780626B2 (en) | 2003-08-08 | 2003-08-08 | Catheter shaft for regulation of inflation and deflation |
PCT/US2004/024741 WO2005016435A2 (en) | 2003-08-08 | 2004-07-29 | Balloon catheter having a cutting member |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1654027A2 true EP1654027A2 (en) | 2006-05-10 |
EP1654027B1 EP1654027B1 (en) | 2011-07-06 |
Family
ID=34116536
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP04779712A Not-in-force EP1654027B1 (en) | 2003-08-08 | 2004-07-29 | Catheter shaft for regulation of inflation and deflation |
Country Status (6)
Country | Link |
---|---|
US (1) | US7780626B2 (en) |
EP (1) | EP1654027B1 (en) |
JP (1) | JP4808617B2 (en) |
AT (1) | ATE515284T1 (en) |
CA (1) | CA2532607C (en) |
WO (1) | WO2005016435A2 (en) |
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- 2004-07-29 JP JP2006522639A patent/JP4808617B2/en not_active Expired - Fee Related
- 2004-07-29 AT AT04779712T patent/ATE515284T1/en not_active IP Right Cessation
- 2004-07-29 WO PCT/US2004/024741 patent/WO2005016435A2/en active Application Filing
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EP1654027B1 (en) | 2011-07-06 |
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WO2005016435A2 (en) | 2005-02-24 |
JP2007501652A (en) | 2007-02-01 |
CA2532607A1 (en) | 2005-02-24 |
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